ISO 9001:2015 Clause 8.2.2

What is ISO 9001:2015 Clause 8.2.2?

Clause 8.2.2, which pertains to the requirements for monitoring and measurement of products and services. This clause is part of Section 8, titled “Operation,” within the ISO 9001 standard.

Key points outlined in Clause 8.2.2 include:

Clause 8.2.2 of ISO 9001:2015 specifically addresses the monitoring, measurement, analysis, and evaluation of the performance of the organization’s quality management system, including the monitoring and measurement of products and services. The key elements of this clause include:

Customer Satisfaction:

Organizations are required to monitor and measure customer satisfaction. This involves obtaining information on whether the organization’s products or services have met customer requirements and expectations.

Internal Audits:

Internal audits of the quality management system are required to ensure its effectiveness. This includes planning, conducting, and reporting on internal audits.

Monitoring and Measurement of Processes:

Organizations need to monitor, measure, and analyze their processes to ensure that they are effectively implemented and maintained. This may involve establishing criteria, methods, and data analysis to ensure process performance.

Monitoring and Measurement of Products:

Requirements for monitoring and measuring product characteristics to verify that they meet specified requirements are outlined in this clause. This includes using suitable equipment and maintaining measurement traceability.

Control of Nonconforming Products:

Procedures for dealing with nonconforming products may include identification, segregation, and disposition of such products.

Organizations are expected to establish and maintain documented information to demonstrate the implementation of these monitoring and measurement processes. This documentation may include procedures, records, and other relevant information.

Other ISO 9001:2015 Clauses:

How does a Company comply with Clause 8.2.2?

Compliance with Clause 8.2.2 of ISO 9001:2015 involves implementing effective monitoring and measurement processes for both the quality management system (QMS) and the products or services provided by the organization. Here are some general steps that a company can take to comply with Clause 8.2.2:

Establish Monitoring and Measurement Processes:

• Identify and define the key processes within the organization’s quality management system.
• Establish criteria for monitoring and measuring the performance of these processes.
• Determine the methods and tools that will be used for monitoring and measurement.

Customer Satisfaction Monitoring:

• Implement processes to gather information on customer satisfaction.
• Define criteria for assessing customer satisfaction, which may include surveys, feedback mechanisms, or other relevant indicators.
• Regularly analyze and evaluate the collected data to identify areas for improvement.

Internal Audits:

• Develop and implement an internal audit program.
• Conduct regular internal audits of the QMS to ensure compliance with ISO 9001 requirements and the effectiveness of the system.
• Document and communicate the results of internal audits, including any identified nonconformities and corrective actions taken.

Monitoring and Measurement of Processes:

• Define criteria for monitoring and measuring the performance of key processes.
• Implement controls to ensure that processes are carried out according to planned arrangements.
• Establish data collection and analysis mechanisms to assess process performance.

Monitoring and Measurement of Products:

• Identify and define the characteristics of products or services that need to be monitored and measured.
• Establish criteria for acceptance and rejection of products based on their characteristics.
• Use appropriate measuring and monitoring equipment to ensure product conformity.

Control of Nonconforming Products:

• Develop procedures for identifying, documenting, and addressing nonconforming products.
• Implement controls to prevent the unintended use or delivery of nonconforming products.
• Define processes for the disposition of nonconforming products, including actions such as correction, segregation, or disposal.

Documented Information:

Maintain documented information that demonstrates the implementation of monitoring and measurement processes. This may include procedures, records, and reports.

Management Review:

• Ensure that the results of monitoring and measurement activities are considered during management reviews of the QMS.
• Use the information to make informed decisions and drive continual improvement.

Organizations need to tailor their approach to Clause 8.2.2 based on their specific industry, context, and the nature of their products or services. Regular reviews and updates of monitoring and measurement processes are essential to ensure ongoing compliance and improvement. Additionally, organizations should refer to the latest version of the ISO 9001 standard for the most current requirements and guidance.

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